Requisition ID 14872BR
Title Director, Drug Safety Case Management
Job Category Medical Information
Job Description PURPOSE:
Oversees the processes for receipt, registration, coding and evaluation (including medical assessment) of all technical complaints and adverse events reported to NNI Product Safety; applies to clinical trials as well as marketed products. Serves as head of the Case Processing Group.
Responsible for Novo Nordisk US (NNI) compliance with US drug and device safety reporting regulations and ICH guidelines. Provides medical and technical information to health care professionals and patients relating to Product safety. Serves as a key expert regarding safety issues and required documentation and investigation of product complaints. Serves as the key contact person between NNI Product Safety and other departments for product complaint issues.
RELATIONSHIPS:
Reports to the Exec. Director, Product Safety with cross-functional working relationships within Medical, Regulatory, Marketing, QA, Legal and IT. Direct reports to this position include Team Leaders, Managers, Sr. Managers and Safety Physicians
This position works closely with counterparts in the NNAS GS Departments, including Safety Operations, IT & Quality and Customer Complaint Center. External relationships include interactions with patients, health care professionals and with FDA personnel concerning product safety reporting matters related to company business. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives.
ESSENTIAL FUNCTIONS:
FDA AND ICH COMPLIANCE:
Serve as the back-up Pharmacovigilance responsible person for NNI.
Applies knowledge of industry regulations and practices regarding product safety to follow the North American Regulatory requirements and SOPs and practices regarding Adverse Event processing and reporting.
Interfaces with NNAS Global Safety to assure compliance with company policies and regulatory standard.
Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety and FDA reportability.
Responsible for development, maintenance and delivery of training in Adverse Event reporting to field employees, e.g. at POA meetings.
Responsible for overseeing input to PSURs, Development Safety Update Reports and IND Annual Reports, as applicable
PRODUCT COMPLAINTS:
Ensures high quality medical and technical product information to health care professionals and patients relating to product safety.
Oversees investigations into adverse drug and device reports with Novo Nordisk products with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal SOPs.
Oversees the preparation of NDA, MDR, and IND expedited safety reports.
Oversees the triage of adverse medical events and malfunction reports with respect to FDA reportability (ie. 7 day, 15 day, MDR).
Supervises the formulation and maintenance of the NNI safety procedures. Assures integration as appropriate within the NNAS adverse event and technical complaint SOPs.
ADMINISTRATION:
Collaborates with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Product Safety records.
Review and approval of business partner agreements for the inclusion of the appropriate safety reporting requirements
Collaborates with the Compliance Group to develop training programs on adverse event data collection and reporting for the appropriate staff.
Develops, maintains and continuously optimizes common processes for adverse event data collection and delivery, reconciliation, drug and event coding, adverse event reporting and resource planning in collaboration with GS
Leads employees involved in the processing and evaluation of adverse event cases. Ensures that adverse event information is processed according to corporate timelines and quality standards.
Oversees NNI safety actions resulting from project team meetings and provides input as required; acts as coaching partner for all direct and indirect reports.
Oversees projects handled by the Continuous Improvement Group in Product Safety
Oversees reviews of documents such as clinical investigation SAE forms and spontaneous adverse event reports.
Oversees the collection and analysis of data from clinical projects for use in Product Safety resource planning.
Participates in safety training opportunities as needed, including presentations for new employees and sales force personnel.
Provides expert assistance to colleagues in other departments in relation to safety activities.
Serves as a member of the Case Processing Management Team and Product Safety Management Team. Ensures that the unit function meets the needs of NNI PS, GS and Clinical Development.
Serves as back-up for the Quality Committee representative for NNI Product Safety.
Responsible for the development of Product Safety’s budgets and fully accountable for adherence to the budget
PHYSICAL REQUIREMENTS:
Not Applicable
DEVELOPMENT OF PEOPLE:
Ensures that direct and indirect reports have annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Participates in departmental strategy, goals and team building
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An advanced degree is required (M.S., Pharm.D., Ph.D., M.D.)
At least eight years of relevant pharmaceutical industry experience is required (e.g., drug safety/pharmacovigilance, regulatory affairs, medical affairs, clinical development) including at least five years of drug safety/pharmacovigilance experience.
Good communication skills and organization skills are required.
A minimum of 4 years supervisory management experience is required.
System knowledge of drug safety databases is mandatory.
Department CMR - PRODUCT SAFETY (1)
Position Location US - Princeton, NJ
City PRINCETON
State/Provinces US - NJ
Degree Required Master's Degree Required
Title Director, Drug Safety Case Management
Job Category Medical Information
Job Description PURPOSE:
Oversees the processes for receipt, registration, coding and evaluation (including medical assessment) of all technical complaints and adverse events reported to NNI Product Safety; applies to clinical trials as well as marketed products. Serves as head of the Case Processing Group.
Responsible for Novo Nordisk US (NNI) compliance with US drug and device safety reporting regulations and ICH guidelines. Provides medical and technical information to health care professionals and patients relating to Product safety. Serves as a key expert regarding safety issues and required documentation and investigation of product complaints. Serves as the key contact person between NNI Product Safety and other departments for product complaint issues.
RELATIONSHIPS:
Reports to the Exec. Director, Product Safety with cross-functional working relationships within Medical, Regulatory, Marketing, QA, Legal and IT. Direct reports to this position include Team Leaders, Managers, Sr. Managers and Safety Physicians
This position works closely with counterparts in the NNAS GS Departments, including Safety Operations, IT & Quality and Customer Complaint Center. External relationships include interactions with patients, health care professionals and with FDA personnel concerning product safety reporting matters related to company business. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department objectives.
ESSENTIAL FUNCTIONS:
FDA AND ICH COMPLIANCE:
Serve as the back-up Pharmacovigilance responsible person for NNI.
Applies knowledge of industry regulations and practices regarding product safety to follow the North American Regulatory requirements and SOPs and practices regarding Adverse Event processing and reporting.
Interfaces with NNAS Global Safety to assure compliance with company policies and regulatory standard.
Maintains up to date knowledge of the regulations and guidelines issued by FDA and ICH as well as other industry sources of information concerning current standards for safety and FDA reportability.
Responsible for development, maintenance and delivery of training in Adverse Event reporting to field employees, e.g. at POA meetings.
Responsible for overseeing input to PSURs, Development Safety Update Reports and IND Annual Reports, as applicable
PRODUCT COMPLAINTS:
Ensures high quality medical and technical product information to health care professionals and patients relating to product safety.
Oversees investigations into adverse drug and device reports with Novo Nordisk products with respect to applicable Federal regulations (IND, NDA, MDR, GMP) and internal SOPs.
Oversees the preparation of NDA, MDR, and IND expedited safety reports.
Oversees the triage of adverse medical events and malfunction reports with respect to FDA reportability (ie. 7 day, 15 day, MDR).
Supervises the formulation and maintenance of the NNI safety procedures. Assures integration as appropriate within the NNAS adverse event and technical complaint SOPs.
ADMINISTRATION:
Collaborates with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Product Safety records.
Review and approval of business partner agreements for the inclusion of the appropriate safety reporting requirements
Collaborates with the Compliance Group to develop training programs on adverse event data collection and reporting for the appropriate staff.
Develops, maintains and continuously optimizes common processes for adverse event data collection and delivery, reconciliation, drug and event coding, adverse event reporting and resource planning in collaboration with GS
Leads employees involved in the processing and evaluation of adverse event cases. Ensures that adverse event information is processed according to corporate timelines and quality standards.
Oversees NNI safety actions resulting from project team meetings and provides input as required; acts as coaching partner for all direct and indirect reports.
Oversees projects handled by the Continuous Improvement Group in Product Safety
Oversees reviews of documents such as clinical investigation SAE forms and spontaneous adverse event reports.
Oversees the collection and analysis of data from clinical projects for use in Product Safety resource planning.
Participates in safety training opportunities as needed, including presentations for new employees and sales force personnel.
Provides expert assistance to colleagues in other departments in relation to safety activities.
Serves as a member of the Case Processing Management Team and Product Safety Management Team. Ensures that the unit function meets the needs of NNI PS, GS and Clinical Development.
Serves as back-up for the Quality Committee representative for NNI Product Safety.
Responsible for the development of Product Safety’s budgets and fully accountable for adherence to the budget
PHYSICAL REQUIREMENTS:
Not Applicable
DEVELOPMENT OF PEOPLE:
Ensures that direct and indirect reports have annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process.
Participates in departmental strategy, goals and team building
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
An advanced degree is required (M.S., Pharm.D., Ph.D., M.D.)
At least eight years of relevant pharmaceutical industry experience is required (e.g., drug safety/pharmacovigilance, regulatory affairs, medical affairs, clinical development) including at least five years of drug safety/pharmacovigilance experience.
Good communication skills and organization skills are required.
A minimum of 4 years supervisory management experience is required.
System knowledge of drug safety databases is mandatory.
Department CMR - PRODUCT SAFETY (1)
Position Location US - Princeton, NJ
City PRINCETON
State/Provinces US - NJ
Degree Required Master's Degree Required